Prefilled syringe delivery system

ABSTRACT

A prefilled syringe with a permanent cylindrical needle guard extending beyond the tip of the needle is disclosed. The needle guard is integral with the syringe holder so as to provide no exposure, selective or otherwise, of the needle. A removable needle guard is further provided. A tubing set is provided with a puncture port which fits in a liquid-tight manner into the cylindrical needle guard. The tubing set further includes anti-siphoning means and low volume tubing.

This is a divisional of copending application Ser. No. 07/280,368 filedon Dec. 6, 1988, now abandoned.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates, in general, to an integrated deliverysystem using a prefilled syringe. In particular, the present inventionrelates to the use of a permanently protected needle in such a system.

2. Description of the Prior Art

In the art of medical syringes, it is well known to provide a protectedneedle which is selectively exposed for a limited period for injectionbefore being returned to a protected state. This protected state of theneedle allows the syringe to be easily handled by medical personnel withreduced risk of accidental injury, injection and subsequent infectionfrom an exposed needle. However, such syringes are still hazardous inthat they may be mishandled by medical personnel so that a needle isinadvertently exposed leading to the possibility of such accidentalinjury, injection and infection.

Examples of these syringes are shown in U.S. Pat. Nos. 4,693,708 and4,681,567. The U.S. Pat. No. 4,693,708 discloses a cylindrical housingof the needle guard which extends and retracts with respect to thesyringe barrel. The U.S. Pat. No. 4,681,567 patent discloses a slidablymounted sheath which acts as a needle guard.

Moreover, it is well-known in the prior art to use a sealed hypodermicsyringe. An example of such a syringe is found in U.S. Pat. No.3,825,003.

Further, in the prior art, it is well known to use a prefilled syringeto deliver medicine or pharmaceutical product to separate medicalapparatus for subsequent infusion into the patient. However, in order tobe compatible with a wide range of apparatus, and possibly due to anill-considered decision to borrow from the art of syringes which areused for direct injection into a patient (which fundamentally mustprovide an exposed needle to allow for direct injection), theseprefilled syringes have typically included a needle which is eitherpermanently exposed or selectively exposed.

This permanent or selective exposure of the needle leads to twodisadvantages.

Firstly, the exposed needle is dangerous to medical personnel.

Secondly, the exposed needle typically has no means for guiding theneedle into a small insertion area of the aforementioned separatemedical apparatus. Inaccurate insertion of the needle into the medicalapparatus can result in contamination of the needle, damage to theneedle or to the apparatus or injury to the user. A good example of suchan apparatus is disclosed in U.S. Pat. No. 4,232,669. This apparatusincludes a needle which is protected by a protective sheath and aremovable protective cap. In order to use this device, the cap isremoved which exposes the needle beyond the protection of the detachableprotective sheath.

It is therefore an object of the present invention to provide aprefilled syringe wherein the needle is permanently shielded.

It is therefore a further object of the present invention to provide aprefilled syringe which includes a means for guiding the needleaccurately into other medical apparatus.

SUMMARY OF THE INVENTION

The present invention is a prefilled syringe delivery system whichincludes a prefilled syringe with a needle permanently protected by acylindrical guard which extends beyond the tip of the needle. The openend of the cylindrical guard serves as a guide for a puncture port to beaccurately positioned with respect to the needle.

The puncture port leads to tubing which includes an anti-siphoning meansand means for connection to other apparatus.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 discloses a side plan view of the prefilled syringe with theplunger at its withdrawn position, the piston screwably removed from theplunger, and a needle sheath over the needle.

FIG. 2 discloses a side plan view of the prefilled syringe with theplunger at its withdrawn position, the piston screwably inserted intothe plunger and the needle sheath removed.

FIG. 3 discloses a cross-sectional view along section 3--3 of FIG. 2.

FIG. 4 discloses a side plan view of the prefilled syringe with thepuncture port inserted over the needle.

FIG. 5 discloses a side plan view of the tubing set of the apparatus,with a Luer® connector shown in phantom under the puncture port.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings in detail wherein like numerals refer tolike elements throughout the several views, apparatus 10 is disclosed inFIGS. 1 and 2.

Syringe 12, which contains the pharmaceutical product, is held withinsyringe holder 14. Syringe 12 is preferably made of breakage resistantglass while syringe holder 14 is made of plastic or some similarmaterial which is resistant to breakage. Needle hub 16 is attached tosyringe 12 and, in turn, is attached to needle 18 (See FIG. 3). Theconnections between syringe 12 and hub 16 and between hub 16 and needle18 are, of course, liquid-tight.

The syringe holder 14 engages the outer curved cylindrical surface ofsyringe 12 with open portions 20 separated by a stem 22 in theintermediate portion thereof. This allows the user to grasp firmlyeither the syringe 12 or the syringe holder 14.

As shown more clearly in FIG. 3, the syringe holder 14 further engagesthe needle hub 16 with a lip 24 as well as surface 25 which allow thesyringe 12 and syringe holder 14 to be rotatable about one another whilepreventing any longitudinal movement of the syringe 12 with respect tothe syringe holder 14.

Needle guard 26 is integrally formed on the proximate end of syringeholder 14 in the shape of a cylinder with the needle 18 as itslongitudinal axis. The needle guard 26 extends from the proximate faceof needle hub 16 to beyond the tip of a needle 18. Needle 18 istherefore permanently protected and not exposed as needle guard 26 isintegral with syringe holder 14 and lip 24 working together with surface25 prevents any relative longitudinal movement of syringe 12 and syringeholder 14.

Apparatus 10 further includes a needle sheath 28 which covers the needle18 to provide further safety during transportation (See FIG. 1) but isremoved during use (See FIG. 2).

The distal end of syringe holder 14 includes outwardly extending annularflanges 30 which serve as finger grips.

A plunger rod 32 is engaged through the distal end of the syringe 12.Piston 36 is comprised of a rubber plunger 34 and a plunger rod 32.Rubber plunger 34 engages the interior of syringe 12 is a liquid-tightbut slidable manner. Plunger rod 32 includes a male threaded portion 38on its proximate end which engages a female threaded portion (not shown)of rubber plunger 34 and a flat handle portion 40 on its distal end.

The female threaded portion of the rubber plunger 34 allows the plungerrod 32 to be disassembled during transportation, even if apparatus 10 isfilled with pharmaceutical product, thereby resulting in a more compactpackage which is not as susceptible to inadvertent movement and loss ofthe pharmaceutical product.

In order to use apparatus 10 effectively, tubing set 41 as disclosed inFIG. 5 is supplied. Tubing set 41 includes an anti-siphoning check valve42, such as is disclosed in U.S. Pat. No. 4,535,820, and an input stem43 leading to cylindrical input 44. Cylindrical input 44 has a diameterjust less than the internal diameter of needle guard 26. Duringoperation, check valve 42 has a positive crack pressure to help preventuncontrolled syringe emptying. A tamper-resistant disk 45 surroundsanti-siphoning check valve 42 and includes an annular hub 46 whichserves as a manual grip for tubing set 41. Disk 45 further forms amechanical interference with the housing of a syringe pump (not shown)to help prevent tampering or inadvertent disconnection. Cylindricalinput 44 includes a rubber puncture port 48 which serves as an injectionsite and further serves as a sterile connection prior to injection byneedle 18. Low volume tubing 50 extends from check valve 42 to a lowerLuer® connector 52 which is covered by a protective cap 54. In itspreferred embodiment, tubing 50 is ninety-six inches long, resulting ina priming volume of 2.1 milliliters for the tubing set 41. Lower Luer®connector 52 provides a means for attachment to secondary medicaldevices (not shown) or to a direct injection needle (not shown) fordirect infusion into the patient.

The cylindrical input 44 may be screwably removed from anti-siphoningcheck valve 42 to expose a Luer® lock connector 56 on the end of stem 43in order to adapt the tubing set 41 to a standard Luer® lock syringe(not shown).

In order to use apparatus 10, the user should firstly be skilled inaseptic technique and accepted IV (intravenous) practice. Syringe 12 isordinarily provided prefilled with pharmaceutical product or medicinefrom the manufacturer or from a central location in the medicalfacility. The user screws plunger rod 32 into rubber plunger 34 so as toform a piston 36. The user removes needle guard 28. The user pushes thepiston 36 to expel all air from the syringe 12. The user may wish to useantiseptic to sterilize puncture port 48. The user holds annular hub 46of disk 45 and guides the cylindrical input 44 and puncture port 48 oftubing set 41 into the interior of needle guard 26. Further, ascylindrical input 44 and puncture port 48 are positioned in needle guard26 prior to insertion of needle 18 through puncture port 48, needle 18is accurately positioned against puncture port 48 prior to insertion.When needle 18 is inserted through puncture port 48, a liquid-proofengagement is formed between apparatus 10 and tubing set 41. The userremoves protective cap 54 from lower Luer® connector 52 and lower Luer®connector is connected to either a direct injection needle (not shown)or to another medical device (not shown). The user pushes the piston 36to expel all air from the syringe 12 and tubing set 41. The user insertsthe syringe holder 14 and piston 36 into a medical pump (not shown) andmakes the appropriate connection to the patient. The user then activatesthe medical pump.

In some rare applications not involving direct infusion into patients,the user may dispense with the medical pump and use piston 36 tomanually inject the medicine or pharmaceutical product into anothermedical device (not shown).

Thus the several aforementioned objects and advantages are mosteffectively attained. Although a single preferred embodiment of theinvention has been disclosed and described in detail herein, it shouldbe understood that this invention is in no sense limited thereby and itsscope is to be determined by that of the appended claims.

What is claimed is:
 1. An apparatus comprising:a syringe having a barreland a piston disposed therein; a syringe holder engaging said syringewith the syringe being disposed within and embraced by the holder;interconnecting surface means between the syringe and syringe holder forpermitting the syringe and holder to be relatively rotatable whilepreventing any longitudinal disassociation of the syringe relative tothe holder; a needle with a tip extending from said syringe andincluding a passage for flow of liquid from said syringe through saidneedle in response to pushing said plunger longitudinally through saidsyringe; and a needle guard substantially permanently attached to andformed integrally with said syringe holder and extending beyond the tipof said needle, said needle guard being formed integrally with saidsyringe holder, the needle guard being a hollow cylindrical shape withsaid needle extending along a portion of a longitudinal axis of saidneedle guard, said syringe being prefilled, a tubing set with a punctureport means of a diameter equal to an interior diameter of said needleguard whereby when said puncture port means is inserted into said needleguard a liquid-proof connection is formed between said puncture portmeans and said needle, said tubing set including anti-siphoning meansleading from said puncture port means, said puncture portion means beingremovable from said anti-siphoning means in order to expose a femalelock connector.
 2. The apparatus of claim 1 wherein said tubing setincludes tubing leading from said anti-siphoning means.
 3. The apparatusof claim 2 wherein said tubing leads from said anti-siphoning means to amale connector.
 4. An apparatus comprising:a syringe having a barrel anda piston disposed therein; a syringe holder engaging said syringe withthe syringe being disposed within and embraced by the holder;interconnecting surface means between the syringe and syringe holder forpermitting the syringe and holder to be relatively rotatable whilepreventing any longitudinal disassociation of the syringe relative tothe holder; a needle with a tip extending from said syringe andincluding a passage for flow of liquid from said syringe through saidneedle in response to pushing said plunger longitudinally through saidsyringe; and a needle guard substantially permanently attached to andformed integrally with said syringe holder and extending beyond the tipof said needle, said needle guard being formed integrally with saidsyringe holder, the needle guard being a hollow cylindrical shape withsaid needle extending along a portion of a longitudinal axis of saidneedle guard, said syringe being prefilled, a tubing set with a punctureport means of a diameter equal to an interior diameter of said needleguard whereby when said puncture port means is inserted into said needleguard a liquid-proof connection is formed between said puncture portmeans and said needle, said puncture port means being removable fromsaid tubing set in order to expose a female lock connector.
 5. Theapparatus of claim 4 wherein said tubing set includes anti-siphoningmeans leading from said puncture port means.
 6. The apparatus of claim 4wherein said tubing set includes tubing leading from said puncture portmeans.
 7. The apparatus of claim 6 wherein said tubing leads from saidpuncture port means to a male connector.